BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PI1-3JUFXC

    MDR report key: 1810055 · Received November 12, 2007

    Report

    Report Number
    1527736-2007-07511
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 17, 2007
    Report Date
    October 31, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY, THE CLIP WAS UNFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PI1-3JUFXC FZP ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4HW9X

    Patients

    Seq Age Sex Outcome Treatment
    1